A phase 2/3 prospective multicenter study of the diagnostic accuracy of prostate specific membrane antigen PET/CT with (18)F-DCFPyL in prostate cancer patients (OSPREY) Journal Article

   

Authors:	Pienta, K. J.; Gorin, M. A.; Rowe, S. P.; Carroll, P. R.; Pouliot, F.; Probst, S.; Saperstein, L.; Preston, M. A.; Alva, A. S.; Patnaik, A.; Durack, J. C.; Stambler, N.; Lin, T.; Jensen, J.; Wong, V.; Siegel, B. A.; Morris, M. J.; and OSPREY Study Group
Article Title:	A phase 2/3 prospective multicenter study of the diagnostic accuracy of prostate specific membrane antigen PET/CT with (18)F-DCFPyL in prostate cancer patients (OSPREY)
Abstract:	Purpose: Prostate specific membrane antigen-targeted positron emission tomography/computerized tomography has the potential to improve the detection and localization of prostate cancer. OSPREY was a prospective trial designed to determine the diagnostic performance of F-18- DCFPyL-positron emission tomography/computerized tomography for detecting sites of metastatic prostate cancer. Materials and Methods: Two patient populations underwent F-18-DCFPyLpositron emission tomography/computerized tomography. Cohort A enrolled men with high-risk prostate cancer undergoing radical prostatectomy with pelvic lymphadenectomy. Cohort B enrolled patients with suspected recurrent/metastatic prostate cancer on conventional imaging. Three blinded central readers evaluated the F-18-DCFPyL-positron emission tomography/computerized tomography. Diagnostic performance of F-18-DCFPyL-positron emission tomography/computerized tomography was based on imaging results compared to histopathology. In cohort A, detection of pelvic nodal disease (with specificity and sensitivity as co-primary end points) and of extrapelvic metastases were evaluated. In cohort B, sensitivity and positive predictive value for prostate cancer within biopsied lesions were evaluated. Results: A total of 385 patients were enrolled. In cohort A (252 evaluable patients), F-18-DCFPyL-positron emission tomography/computerized tomography had median specificity of 97.9% (95% CI: 94.5%-99.4%) and median sensitivity of 40.3% (28.1%-52.5%, not meeting prespecified end point) among 3 readers for pelvic nodal involvement; median positive predictive value and negative predictive value were 86.7% (69.7%-95.3%) and 83.2% (78.2%-88.1%), respectively. In cohort B (93 evaluable patients, median prostate specific antigen 11.3 ng/ml), median sensitivity and positive predictive value for extraprostatic lesions were 95.8% (87.8%-99.0%) and 81.9% (73.7%-90.2%), respectively. Conclusions: The primary end point for specificity was met while the primary end point for sensitivity was not. The high positive predictive value observed in both cohorts indicates that F-18-DCFPyL-positive lesions are likely to represent disease, supporting the potential utility of F-18-DCFPyL-positron emission tomography/ computerized tomography to stage men with high-risk prostate cancer for nodal or distant metastases, and reliably detect sites of disease in men with suspected metastatic prostate cancer.
Keywords:	neoplasm staging; prostatic neoplasms; neoplasm metastasis; imaging; ct; therapy; expression; molecular; detect
Journal Title:	Journal of Urology
Volume:	206
Issue:	1
ISSN:	0022-5347
Publisher:	Elsevier Science, Inc.
Date Published:	2021-07-01
Start Page:	52
End Page:	60; editorial comment 60-61
Language:	English
ACCESSION:	WOS:000711790900014
DOI:	10.1097/ju.0000000000001698
PROVIDER:	wos
PMCID:	PMC8556578
PUBMED:	33634707
Notes:	Article -- Source: Wos

https://synapse.mskcc.org/synapse/works/has_related_data_chk/190814